ASI GenASIs image analysis system wins FDA nod

The US Food and Drug Administration (FDA) has cleared Applied Spectral Imaging's (ASI) GenASIs automated scanning and image analysis system.

GenASIs Scan and Analysis is used as an adjunctive automated enumeration tool to assist the cytogenetics and to facilitate pathologist to detect amplifications of the chromosome 17 and HER-2/neu gene in human breast cancer specimens.

ASI said the detection and analysis is concluded via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens.

ASI CEO Limor Shiposh said they plan to expand their portfolio of FDA cleared tools in their GenASIs platform to better serve their customers in achieving more accurate clinical results, quicker and more cost effectively.